Sign in

NCT05200260RecruitingPhase 2

Surgery Combined With Maintenance Targeted Therapy in the Treatment of Advanced Ovarian Cancer

A Prospective, Multicenter, Randomized Phase II Trial on Optimal Timing of Surgery Combined With Maintenance Targeted Therapy in the Treatment of Advanced Ovarian Cancer

Source: ClinicalTrials.gov · Last updated 10 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Optimal Timing of Surgery combined with Maintenance Therapy in the Front-line Treatment of Advanced Ovarian Cancer

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
220 (estimated)
First submitted
17 Jan 2022
Start date
13 Jul 2022
Primary completion date
30 Jun 2027
Lead sponsor
Shanghai Gynecologic Oncology Group
NCT number
NCT05200260

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 220
  • From 13 Jul 2022 to the primary completion date, 30 Jun 2027
  • 9 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise adherence to the protocol.

Other illness

  • Non-epithelial ovarian malignancies and borderline tumors
  • Low grade ovarian cancer
  • Mucinous ovarian cancer
  • Patient has a known hypersensitivity to the components of olaparib/bevacizumab or its excipients
  • Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ, thyroid carcinoma, or breast carcinoma (without any signs of relapse or activity, early-stage).
  • Other conditions, such as religious, psychological, and other factors, that could interfere with the provision of informed consent, compliance to study procedures, or follow-up.

Other

  • Complete cytoreduction cannot be achieved according to preoperative evaluation, including pulmonary and hepatic parenchymal metastases, unresectable extensive pleural metastases, multiple thoracic lymph nodes metastases, brain or bone metastases

Who the study is looking for

  • Females aged ≥ 18 years.
  • Pathologic confirmed stage IIIC and IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma
  • Low, Middle tumor burden and high tumor burden with cPCI score ≤ 12 based on pre-operative CT or PET/CT examination
  • Complete cytoreduction can be achieved based on CT or PET/CT examination
  • Patients must agree to undergo BRCA (breast cancer gene) and HRD (homologous recombination deficiency) testing
  • Performance status (ECOG 0-2)
  • Adequate bone marrow, renal and hepatic function to receive chemotherapy and subsequent surgery:
    • white blood cells \>3,000/µL, absolute neutrophil count ≥1,500/µL, platelets ≥100,000/µL, hemoglobin ≥9 g/dL,
    • serum creatinine \<1.25 x upper normal limit (UNL) or creatinine clearance ≥60 mL/min according to Cockroft-Gault formula or to local lab measurement,
    • serum bilirubin \<1.25 x UNL, AST(SGOT) and ALT(SGPT) \<2.5 x UNL.
  • Comply with the study protocol and follow-up.
  • Patients who have given their written informed consent.

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (9)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First People's Hospital of Foshan
Coordinator of this site? Confirm its status
FoshanChinaRecruiting
Sun Yet-Sen University Cancer Center
Coordinator of this site? Confirm its status
GuangzhouChinaRecruiting
Zhejiang Cancer Hospital
Coordinator of this site? Confirm its status
HangzhouChinaRecruiting
The First Affiliated Hospital Zhejiang University School of Medicine
Coordinator of this site? Confirm its status
HangzhouChinaRecruiting
The First Affiliated Hospital of University of Science and Technology of China
Coordinator of this site? Confirm its status
HefeiChinaRecruiting
Zhongshan Hospital,Fudan University
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting
Obstetrics and Gynecology Hospital of Fundan University
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting
Fudan University Cancer hospital
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.